NCT07446153 is a Phase 1/Phase 2 clinical trial of HRS-8364 Tablet in Solid Tumor, sponsored by Jiangsu HengRui Medicine Co., Ltd..

Who is sponsoring NCT07446153?

NCT07446153 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What drugs are being tested in NCT07446153?

Interventions in NCT07446153: HRS-8364 Tablet.

What condition does NCT07446153 study?

NCT07446153 studies Solid Tumor.

Is NCT07446153 still recruiting?

NCT07446153 is currently recruiting now. Last updated 2 April 2026.

Last reviewed 2026-04-02 · How we verify

NCT07446153

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open Label, Multicenter Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects

Recruiting now Phase 1/Phase 2 Last updated 2 April 2026

What this trial tests

Phase 1/Phase 2 trial testing HRS-8364 Tablet in Solid Tumor in 282 participants. Currently enrolling.

Timeline

19 March 2026

Primary endpoint
1 December 2028

1 December 2029

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	282
Start date	19 March 2026
Primary completion	1 December 2028
Estimated completion	1 December 2029
Sites	2 locations across China

Drugs / interventions tested

HRS-8364 Tablet — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The Dose-Limiting Toxicity (DLT)
Time frame: Post-dose at Day 1 to Day 21.
The Maximum Tolerated Dose (MTD)
Time frame: Post-dose at Day 1 to the end of treatment visit, about 1 year.
Recommended dosage for Phase II (RP2D)
Time frame: Post-dose at Day 1 to the end of treatment visit, about 1 year.
Incidence and severity of adverse events (AEs)
Time frame: From signing the informed consent form to safety follow-up completed, about 1 year.
Objective Response Rate (ORR)
Time frame: From the first administration to the end of treatment visit, about 1 year.

Sponsor's own description

This study is an open, multicenter, Phase I/II clinical trial, divided into three stages: dose escalation, dose expansion and efficacy expansion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07446153 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
Last refreshed: 2 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07446153.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing